To build diversity into clinical trials, collaborate at the community level
Diversity in clinical trials is a “scientific imperative”, but how can industry bridge the gap between “why” and “how”?
Removing barriers to clinical trial participation for underserved groups is an essential part of addressing health inequalities. Getting there, however, is easier said than done.
The Food and Drug Administration’s (FDA) draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials, recommends sponsors develop and submit a race and ethnicity diversity plan early in clinical development.
Speakers at a recent Patients as Partners webinar on the document welcomed its publication, and explained how community and collaboration were the keys to turning theory into practice.
Why, not how
Part of the FDA’s Diversity in Clinical Trials Initiative, the draft guidance says adequate representation in clinical trials helped “ensure data generated during drug development reflects the racial and ethnic diversity of the population expected to use the medical product”.
Bridgette McCullough, founder and CEO of advocacy group ACIRAH, said that African Americans made up almost 40% of the US population, but just 2 to 5% of clinical trial participants.
“How do you create better health outcomes for African Americans? How do you create better efficacy in the drugs that are being prescribed to work in a black body, at the cellular level?” Clinical trial participation, she went on, was vital.
Samit Hirawat, chief medical officer for global drug development at Bristol Myers Squibb called it a “scientific imperative”. “This is a matter of health equity,” he said. “It is important that we understand that everybody is utilising the drug in the appropriate way.”
Andrea Goodman, senior vice president of patient support and research strategy at the Colorectal Cancer Alliance, agreed, adding that the guidance, along with the sector’s increasing focus on diversity, was a huge step in the right direction.
“The first success is acknowledging that we have historically run a system for the most advantaged patients: we do not have a system for all. Naming this need allows us the foundational understanding that we're not all starting from the same place of access, trust, and opportunity,” she added.
While the FDA document is rich in the “whys” of greater diversity in research, however, it was lacking in the “hows”, said the speakers. “It talks about representation, but what it doesn't talk about is how we're going to achieve that – and the ‘how’ is the most important part,” said Hirawat.
Community-led
According to the FDA, the barriers to participation are multiple. They include mistrust of the clinical research system, unfeasible trial design, and time and resource constraints. Language and cultural differences, health literacy, religion, limited access, and a lack of awareness also all play a role.
But Hirawat said the industry had to look deeper than that. “Nobody's writing inclusion / exclusion criteria to say a person with darker skin or lighter skin is excluded, or people with the last name of XYZ is excluded, so why do we not get those patients in clinical trials?
“The problem is not just patients not trusting the system, but that we don't have diverse clinical trialists who can attract diverse patient populations and we don't have clinical trial sites in the areas where diverse underrepresented populations actually live,” he said.
BMS has been working to address this for the last few years, he went on, by funding the preparation of clinical trial sites in underserved areas and recruiting clinical investigators and coordinators from underserved communities. The company’s health equalities charity, The BMS Foundation, is also training clinical trial investors and medical students in clinical trial diversity from the grassroots level.
“You have to have a long-term plan in terms of addressing it at every single level,” said Hirawat.
McCullough, whose organisation provides a platform that connects Black Americans to clinical trials, agreed with this approach. “ACIRAH is founded and rooted in the Black community. We are not sitting on Michigan Avenue expecting Black people to enter our world.
“We are in their homes, their churches, their community centres, their schools… taking the mystery away, shining a light on what a clinical trial is.”
Collaborate
Change requires a fundamental shift in how the research industry is structured and operated – and no one organisation can do that alone.
“It is a different mindset that we are working towards,” said Goodman. “Having patient investigators, and truly looking to patients and those with lived experience to inform protocol development, eligibility criteria, recruitment, planning, and long-term trust building will get us way further than we are right now.”
An increase in pharma organisations seeking patient input, however, is bound to place additional pressure on already-stretched patient advocacy groups, said Ellen Coleman, president and CEO of VOZ Advisors.
“Is there a way for us to elevate this to the non-competitive space? Could there be solutions that don't entail each pharma company going to each organisation for the same information?,” she said, adding that cross-organisational disease-specific or health equality-focused advisory councils could be one solution.
Strong foundations
Building the foundations of a more equitable system will depend on the sector’s ability to work together.
“There needs to be a large-scale, rather than a company-by-company, effort to address the infrastructure needs of the clinical trials, such as setting up the community clinical trials sites,” said Coleman, and Hirawat agreed.
“We are playing a very small role in a very large movement, and we can't do it alone. Every single one of us will have to play a big role in getting this done,” he said.
About the author
Amanda Barrell is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, HCPs and the public.
